FDAFDA · Food and drugs·Recall number Z-0627-2013
Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.
Published January 9, 2013 · Recall initiated: November 2, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Inc.
- Distributor
- Worldwide Distribution - USA including AR, GA, SC, TX, TN and internationally to France, United Arab Emirates, Australia, Brazil, Canada, Switzerland, China, Germany, Spain, United Kingdom, Italy, Japan, Sweden, Thailand, Turkey, Serbia, and South Africa.
- Lot
- Class I exempt Device Listing Number A922956
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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